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The FDA added it to injectable semaglutide in January 2025, and it climbs the dose axis like everything else. Burning or tingling skin tracks the dose, not the weight lost, and an active-comparator study put the risk about twice that of another weight-loss drug. The mechanism is unsettled: the tempting "it is the drugs signaling arm" story is ruled out, because the strongest GLP-1 signaler in the class carries no such signal

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The proof-of-concept analysis focused on a subset of participants aged 1235 years who achieved at least 10% body weight loss during treatment

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